MAUDE Adverse Event Report: STRYKER GMBH DRILL SLEEVE, LOCKING 3.1MM, SHORT; PLATE, FIXATION, BONE

Model Number	705004
Medical Device Problem Codes	Overheating of Device (1437); Smoking (1585); Noise, Audible (3273); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "when i was using the 3.1 drill for the axsos locking screw, there was a strange noise, heat, and smoke.I tried to remove the locking sleeve, but it was stuck with the tip of the drill and did not come off." additionally reported: "saline was applied to cool the heat-generating part.Replaced with another drill tip and sleeve.The procedure was completed successfully.".
Event or Problem Description
As reported: "when i was using the 3.1 drill for the axsos locking screw, there was a strange noise, heat, and smoke.I tried to remove the locking sleeve, but it was stuck with the tip of the drill and did not come off." additionally reported: "saline was applied to cool the heat-generating part.Replaced with another drill tip and sleeve.The procedure was completed successfully.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the reported failure mode.Device inspection revealed the following: the received drill and drill sleeve were received in a stuck state.Both were having signs of intense and frequent usage they both couldn¿t be dis-assembled.This gives an indication that most likely a metal debris or bone residue is clogged inside the cannulation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Since the devices could not be dis-assembled, it was not possible to determine the exact root cause of the complaint.However, visual evidence indicates towards a potential clogging of the cannulation by metal debris generated inside due to a long and intense usage.As the event suggests, that there was heat and smoke, it reflects towards possible clogging and subsequent jamming.If any further information is provided, the complaint report will be updated.

• Brand Name: DRILL SLEEVE, LOCKING 3.1MM, SHORT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 10131027
• Report Number: 0008031020-2020-01553
• Device Sequence Number: 1762110
• Product Code: HRS
• UDI-Device Identifier: 07613327083606
• UDI-Public: 07613327083606
• Combination Product (Y/N): N
• PMA/510(K) Number: K141121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 705004
• Device Catalogue Number: 705004
• Device Lot Number: K061E08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Initial Date Received by Manufacturer: 05/12/2020
• Supplement Date Received by Manufacturer: 08/14/2020
• Initial Report FDA Received Date: 06/08/2020
• Supplement Report FDA Received Date: 09/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR